Clinical trials: Early-stage or Locally Advanced HER2-positive Breast Cancer
Breast Cancer, HR Positive, HER2 Positive Breast Cancer
Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer
This is a single-arm, prospective, multicenter, phase II clinical study evaluating the efficacy and safety of a chemotherapy-free neoadjuvant regimen in patients with HR-positive/HER2-positive (HR+/HER2+) early or locally…
- Trial name
- NCT07795424
- Testing
- Culmerciclib, Letrozole, Trastuzumab (TQB211)
- Where
- China
- Volunteers
- 33 people
- Sponsor
- Shengjing Hospital
HER2-positive Breast Cancer
Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer
This study is a one-arm, open, phase II clinical study, and the study subjects are locally advanced and inflammatoryPatients with sexual or early HER2-positive breast cancer entered the trial period after signing informed…
- Trial name
- NCT04481932
- Testing
- Trastuzumab combined with Pyrotinib and chemotherapy
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Peking University
Breast Cancer
A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer
This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant…
- Trial name
- BERENICE (NCT02132949)
- Testing
- 5-Fluorouracil, Cyclophosphamide, Docetaxel
- Where
- 80 sites in United States, Canada and 10 more
- Volunteers
- 401 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer
This is a prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive early stage or locally…
- Trial name
- NCT03847818
- Testing
- Pyrotinib+Trastuzumab+Docetaxel+Carboplatin
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- Shandong University
Breast Cancer
Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer
This is a single-center, randomized, open-label, phase II interventional study. Eligible patients will be randomized 1:1 to receive either Trastuzumab-rezetecan (4.8 mg/kg Q3W) or T-DXd (5.4 mg/kg Q3W) for 8 neoadjuvant cycles.
- Trial name
- NCT07416253
- Testing
- Trastuzumab rezetecan, Trastuzumab deruxtecan
- Volunteers
- 68 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.
The purpose of this research study is to collect samples of blood and stool and analyse primary tumor from participants with breast cancer to see how the bacteria in the body affect cancer and how well it responds to treatment.
- Trial name
- NCT06126003
- Testing
- Observation
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- BioCorteX Inc
Breast Cancer
A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.
This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer.
- Trial name
- NCT00545688
- Testing
- Herceptin, Docetaxel, Pertuzumab
- Where
- 77 sites in Australia, Austria and 16 more
- Volunteers
- 417 people
- Sponsor
- Hoffmann-La Roche
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in…
- Trial name
- NCT06038539
- Testing
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Biocon Biologics UK Ltd
HER2-Positive Metastatic Breast Cancer, HER2-Negative Metastatic Breast Cancer
Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer
This is a Phase Ib, open-label, two-stage study with two active regimens in each stage designed to evaluate the safety and tolerability of combination treatment with atezolizumab, trastuzumab, and pertuzumab (with and without…
- Conditions
- HER2-Positive Metastatic Breast Cancer, HER2-Negative Metastatic Breast Cancer, Locally Advanced or Early Breast Cancer
- Trial name
- NCT02605915
- Testing
- Atezolizumab, Carboplatin, Docetaxel
- Where
- 20 sites in United States
- Volunteers
- 98 people
- Sponsor
- Hoffmann-La Roche
HER2 Positive Early or Locally Advanced Breast Cancer
A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin® in Women with Newly…
- Trial name
- NCT02149524
- Testing
- Herceptin (trastuzuamb), SB3 (proposed trastuzumab biosimilar)
- Where
- Czechia
- Volunteers
- 875 people
- Sponsor
- Samsung Bioepis Co., Ltd.
HER2 Positive Breast Cancer
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Vinorelbine in Trastuzumab-refractory HER2-Positive Breast Cancer.
This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus Vinorelbine given as neoadjuvant treatment in Trastuzumab-refractory HER2…
- Trial name
- NCT03947242
- Testing
- Pyrotinib and Trastuzumab plus Vinorelbine
- Volunteers
- 48 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer, HER2-positive Breast Cancer
Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP
This is a prospective, multi-center, single-arm, phase 2 exploratory study to evaluate the efficacy and safety of adding 4 cycles of Trastuzumab Rezetecan (T-DXh), an anti-HER2 antibody-drug conjugate, as continued neoadjuvant…
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Early-stage Breast Cancer, Locally Advanced Breast Cancer
- Trial name
- NCT07589699
- Testing
- Trastuzumab Rezetecan
- Volunteers
- 59 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
HER2-positive Early Breast Cancer
A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer
The study will compare PK, efficacy, safety, and immunogenicity of SIBP-01 (Trastuzumab Biosimilar) in combination with Docetaxel and Carboplatin versus Herceptin® (CN-Trastuzumab) approved in the CN in combination with Docetaxel…
- Trial name
- NCT03989037
- Testing
- SIBP-01, Herceptin, Docetaxel
- Where
- China
- Volunteers
- 580 people
- Sponsor
- Shanghai Institute Of Biological Products
Breast Cancer
Treatment of Breast Cancer With Trastuzumab + HS627/ Pertuzumab + Docetaxel
The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks).
- Trial name
- NCT04514419
- Testing
- HS627, Pertuzumab
- Where
- China
- Volunteers
- 408 people
- Sponsor
- BioRay Pharmaceutical Co., Ltd.
Breast Cancer
Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy of neoadjuvant Navelbine plus trastuzumab and Pertuzumab versus Docetaxel plus trastuzumab and Pertuzumab given as neoadjuvant treatment…
- Trial name
- NCT04665986
- Testing
- Navelbine, Docetaxel
- Volunteers
- 50 people
- Sponsor
- Zhejiang Cancer Hospital
Breast Cancer Invasive
Pyrotinib, Trastuzumab, Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
This study aims to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.
- Trial name
- NCT04398914
- Testing
- Pyrotinib, Trastuzumab, Pertuzumab
- Where
- China
- Volunteers
- 216 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Locally Advanced Breast Cancer, Metastatic Breast Cancer
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
The goal of this national, multicenter single arm phase II clinical trial is to study the efficacy, safety and tolerability of the administration of Trastuzumab Deruxtecan (T-DXd) in HER2-positive locally advanced or metastatic…
- Trial name
- TRANSCENDER (NCT05744375)
- Testing
- Trastuzumab deruxtecan
- Where
- 19 sites in Spain
- Volunteers
- 2 people
- Sponsor
- Spanish Breast Cancer Research Group
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC
This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer.
- Trial name
- NCT07797218
- Testing
- Docetaxel, Pyrotinib, Trastuzumab (Herceptin)
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Breast Cancer
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel
This is an Asia-Pacific regional, randomized, double-blind, multicenter trial designed to evaluate treatment with trastuzumab + pertuzumab + docetaxel compared with trastuzumab + placebo + docetaxel in chemotherapy-naïve…
- Trial name
- PEONY (NCT02586025)
- Testing
- FEC Chemotherapy, Surgery, Docetaxel
- Where
- 23 sites in China, South Korea and 2 more
- Volunteers
- 329 people
- Sponsor
- Hoffmann-La Roche
Early or Locally Advanced HER2-positive Breast Cancer
A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer
This randomized, controlled, open-label, multicenter study will evaluate the safety and efficacy of KN026 in combination with HB1801 ± Carboplatin as neoadjuvant therapy in patients with early or locally advanced HER2-positive…
- Trial name
- Neo-Healer (NCT06747338)
- Testing
- KN026, HB1801, Pertuzumab
- Where
- China
- Volunteers
- 520 people
- Sponsor
- Shanghai JMT-Bio Inc.